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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03859778
Other study ID # CHU-427
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 14, 2019
Est. completion date March 31, 2019

Study information

Verified date February 2019
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The pharmacist in his professional activity may have to manage opioid dependent patients. This professional activity will result in the provision of opioid substitution treatment (OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of OST has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients under OST is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed OST in France.

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with opioid-dependent patients, even though these pharmacists have received education in the management of addictions during their studies. Indeed, it can consider that these courses should help to better understand the addictive disease both in its nosological / semiological and therapeutic components. Thus, it would be interesting to evaluate the impact of addiction education on pharmacists' perception of opioid dependence. In this perspective, it would be interesting to focus on pharmacy students.

The objective of this study will be to evaluate the perception by pharmacy students of opioid dependent patients. Investigator would like to know if pharmacy students consider opioid addiction to be an illness and whether having taken education on drug use and addictions changes this perception.


Description:

This observational and cross-sectional study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).

French pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online.


Recruitment information / eligibility

Status Completed
Enrollment 2034
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- French pharmacy students

Exclusion Criteria:

- Age <18 years

- Other health students

- Graduated pharmacist

- First year pharmacy student

Study Design


Related Conditions & MeSH terms


Intervention

Other:
survey
French pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online

Locations

Country Name City State
France Chu Clermont-Ferrand Clermont-Ferrand

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand UFR Pharmacie (Clermont-Ferrand)

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perception of opioid / opiate dependence as a disease visual analogic scale: -10 (it is not a disease), 0 (neutral) and +10(it is a disease) At day 1
Secondary Proportion of courses on drug addiction during pharmacy studies yes/no (percentage) At day 1
Secondary Study year of courses on drug addiction during pharmacy studies 2nd, 3rd, 4th, 5th and/or 6th year of study in pharmacy At day 1
Secondary Perception of the pharmacist's missions on the dispensing of opioid substitution treatments (buprenorphine and methadone) and harm reduction kit / single use syringe visual analogic scale: -10 (it's not normal), 0 (neutral) and +10 (it's normal) At day 1
Secondary Perception of the efficacy of opioid substitution treatments (buprenorphine and methadone) visual analogic scale: -10 (it is not effective), 0 (neutral) and +10 (it is effective) At day 1
Secondary Proportion of realization of internships or temporary employment in pharmacy yes / no (percentage) At day 1
Secondary Proportion of delivery of opioid substitution treatments (buprenorphine and methadone) yes / no (percentage) At day 1
Secondary Proportion of tobacco (cigarettes) use yes / no (percentage) At day 1
Secondary Proportion of electronic cigarettes use yes / no (percentage) At day 1
Secondary Proportion of alcohol use yes / no (percentage) At day 1
Secondary Proportion of alcohol use (>10 alcohol units per week) yes / no (percentage) At day 1
Secondary Proportion of cannabis use yes / no (percentage) At day 1
Secondary Frequency of cannabis use (for users) Daily, weekly, monthly, occasional or experimentation At day 1
Secondary Proportion of personal experience with a relative having or having had a problem of drug use yes / no (percentage) At day 1
Secondary Academic year in pharmacy at the time of the answer 2nd / 3rd / 4th / 5th / 6th year of study in pharmacy At day 1
Secondary Estimation of attendance to courses Visual analogic scale: 0 (no attendance) - 100 (full attendance) At day 1
Secondary Estimation of annual average mark during the past university year <10, 10-12, 12-14, 14-16 and >16/20 At day 1
Secondary Demographic information age and sex At day 1
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